Pfizer reveals heart attack risk from Celebrex, stock plunges
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NEW YORK (AFP) - Drug giant Pfizer announced that a trial revealed a heart attack risk with the blockbuster Celebrex arthritis and pain medicine, sending shares into a tailspin.
The risk appeared in one of two cancer studies.
"These clinical trial results are new. The cardiovascular findings in one of the studies are unexpected and not consistent with the reported findings in the second study," Pfizer chairman and chief executive Hank McKinnell said in a statement.
Rival pharmaceutical giant Merck had already announced a global withdrawal of its anti-pain drug Vioxx, on September 30, prompted by a study showing it increased the risk for strokes and heart attacks. Merck's share price has crumbled and it is now engulfed in lawsuits.
Pfizer shares plunged 4.98 dollars, or 17.18 percent, to 24.00 dollars in early trade.
The slump wiped out 38 billion dollars in Pfizer market capitalization in less than one hour.
A study into the use of Celebrex to prevent benign tumours, or adenomas, showed patients taking 400mg and 800mg of Celebrex daily had an approximately 2.5 fold increase in their risk of experiencing a major fatal or non-fatal cardiovascular event compared to those patients taking placebo, according to the National Cancer Institute (news - web sites) (NCI).
Based on the "statistically significant" findings, the sponsor of the trial, the NCI, suspended the dosing of Celebrex. The news was given to Pfizer late Thursday.
A separate study, however, into whether Celebrex can prevent polyps showed no increased heart risk for Celebrex patients taking 400mg daily compared with those taking placebo.
Until now, Pfizer's Celebrex -- used by 26 million people according to the Pfizer Internet site -- had not been shown to produce any increased risk of heart attacks.
The drug hauled in 2.29 billion dollars of revenue in the first nine months of 2004, more than double to 1.07 billion dollars raked in for the same period last year.
"Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world," McKinnell said.
Celebrex is approved for use in the United States for the treatment of arthritis and pain, at recommended doses of 100mg to 200mg daily for osteoarthritis and 200mg to 400mg a day for rheumatoid arthritis.
The results of the adenoma study, known as the APC trial, differed from the second study and from "the large body of data that we and others have accumulated over time, in which an increased risk of serious cardiovascular events in arthritis patients, even at higher-than-recommended doses, had not been seen," said Pfizer president for worldwide development Joseph Feczko.
"Celebrex is an important medicine that provides necessary pain relief to many patients. Patients being treated with Celebrex should discuss appropriate treatment options with their healthcare professionals."
Last month, Pfizer rejected a story in the Canadian paper, National Post, that Celebrex had been suspected of causing 14 deaths and other serious side effects. Pfizer said the report was "misleading" and based on non-scientific evidence.
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17-12-2004, 16:13
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